FDA 483 - Minteq UK Limited - August 29, 2025

Minteq UK Limited, an API manufacturer in Birmingham, United Kingdom, was cited for numerous significant deficiencies related to its quality unit, procedures, and laboratory controls. The inspection revealed a systemic lack of written procedures, inadequate raw material testing, insufficient data backup, and a failure to ensure proper equipment calibration and employee GMP training. These issues indicate a broad breakdown in the firm's quality management system for API manufacturing.